Validation Engineer - Mason Area

We partner with manufacturers across Mason seeking Validation Engineers who want more than a lateral move. These companies hire intentionally, and we connect them with professionals ready for roles that fit.

• →Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software.
• →Perform risk assessments and generate validation plans in accordance with regulatory requirements (e.g., FDA, ISO).
• →Analyze validation data, write comprehensive reports, and present findings to cross-functional teams.
• →Investigate deviations and out-of-specification results during validation activities, implementing corrective actions.
• →Maintain validation documentation and ensure compliance with internal procedures and external regulations.
• →Collaborate with engineering, quality, and production teams to integrate validation activities into the product lifecycle.
• →Support the development and implementation of change control processes for validated systems.
• →Participate in regulatory audits and inspections, providing documentation and technical expertise.

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
• Strong understanding of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience with validation lifecycle activities including IQ, OQ, PQ, and computer system validation (CSV).
• Excellent technical writing skills for creating and reviewing validation protocols and reports.

• Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, JMP).
• Familiarity with automation systems and software validation (e.g., SCADA, DCS, PLC).
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with risk management tools and techniques (e.g., FMEA, PHA).
• Knowledge of cybersecurity principles as they apply to manufacturing systems.

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Engineer (Validation), QA Validation Engineer, Validation Specialist, Validation Lead, Validation Manager

The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic—they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at https://www.thepivotgroup.org.

If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at https://www.thepivotgroup.org. The Pivot Group Network offers resources to support your search—market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.